Specialist in pharmacokinetics with over 19 yr of experience in pharmaceutical industry as pharmacokineticist: at Active Biotech AB (Lund),
Novo Nordisk A/S (Copenhagen), senior consultant at Semcon Caran AB (Stockholm) and since March 2013 as independent consultant. As consultant, various assignments in more than 20 companies developing both small molecule drugs and biologics.
Degree in Chemistry and a PhD in kinetics and toxicology (Karolinska Institute and National Institute of Working Life) and post-doc studies (Institute of Occupational Health, Switzerland) within the fields of pharmacokinetics (PK), drug metabolism (DM), toxicology, and bioanalysis.
Supporting nonclinical and clinical programs with PK expertise as well as PK aspects during Due Diligence, covering all development phases from drug discovery until regulatory filing for market authorization.
Additional training in quality assurance (QA) activities, including audits, SOP and implementation of good laboratory practice (GLP).
More than 10 publications in peer-reviewed papers as well as risk assements.
Physiological based pharmacokinetic modelling (PBPK), PKPD analysis as well as simulations. Software: mainly using Phoenix WinNonlin and Berkeley Madonna